NCT06578676

Brief Summary

The purpose of this study is to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg Ezetimibe/Rosuvastatin in steady state in healthy volunteers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 4, 2024

Last Update Submit

August 27, 2024

Conditions

Type 2 DiabetesDyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration

  • AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

Secondary Outcomes (8)

  • Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

  • Cmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

  • AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

  • AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

  • Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin

    0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration

  • +3 more secondary outcomes

Study Arms (2)

Empagliflozin 25mg

EXPERIMENTAL

* Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)

Drug: Empagliflozin 25 MGDrug: Ezetimibe/Rosuvastatin 10/10mgDrug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Rosuvastatin/Ezetimibe 10/10mg

EXPERIMENTAL

* Period 1: Ezetimibe/Rosuvastatin (QD, 7d) * wash-out: 14d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)

Drug: Ezetimibe/Rosuvastatin 10/10mgDrug: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

Interventions

Empagliflozin 25 MGDRUG

PO, QD

Empagliflozin 25mg
Ezetimibe/Rosuvastatin 10/10mgDRUG

PO, QD

Empagliflozin 25mgRosuvastatin/Ezetimibe 10/10mg
Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mgDRUG

PO, QD

Empagliflozin 25mgRosuvastatin/Ezetimibe 10/10mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age: 19 and over , healthy volunteer
  • Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²

You may not qualify if:

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
  • Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university hospital

Daegu, Gyeongsangbuk-do, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dyslipidemias

Interventions

empagliflozinEzetimibeRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Central Study Contacts

Young-Ran Yoon, PhD

CONTACT

+82 53-200-6351yry@knu.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 2 sequence
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2024

First Posted

August 29, 2024

Study Start

June 20, 2024

Primary Completion

September 2, 2024

Study Completion

November 30, 2024

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)